FDA approval takes 60 days on a 510 if the FDA has “no questions”. If there are none, Actipatch is approved sometime next week by FDA and we should get an immediate press release. If the FDA has questions, at anytime during the 60 days, the 60 day clock restarts. So, if there are/were questions and the company does not inform the shareholders, we are in no man’s land with regard to the timing. Then you have to ask, why were the shareholders not informed there were questions... another concern.
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